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ISO 13485

ISO 13485:2003 Quality Management System for Medical Devices

ISO 13485 is a Management Systems Standard specifically developed for the manufacture of Medical Devices published by International Organization for Standardization in 2003. The standard provides a framework for a comprehensive management system for the design and manufacture of medical devices. Its primary objective is to facilitate harmonized medical device regulatory requirements. ISO 13485 contains requirements that are essential for any organization operating at any tier in the medical device and pharmaceutical supply chain.

It is especially relevant to manufacturers who wish to demonstrate applicable regulatory requirements, and by organizations whose services support medical device manufacturers.

Essentials of ISO 13485:2003

  • Implementation of a Quality Management System with several enhancements
  • Risk Management approach to product development and product realization
  • Validation of processes
  • Compliance with statutory and regulatory requirements
  • Effective product traceability and recall systems

 

Benefits of ISO 13485:2003:

  • Customer satisfaction
  • Reduced operating costs
  • Improved stakeholder relationships
  • Legal compliance
  • Improved risk management
  • Proven business credentials
  • Ability to win more business

 

Our Services:

We offer comprehensive services that will help you achieve your ISO 13485:2003 quality goals. We provide assistance to:

 

  • Conduct an initial gap analysis
  • Help you establish policies and objectives
  • Identify documentation requirements
  • Make assignments and prepare schedules
  • Prepare documentation
  • Coordinate document preparation, reviews, approvals, and production
  • Manage implementation schedules, training, follow-up actions
  • Help you seek accreditation certificate for ISO 13485:2003

 

 

In addition to consulting (online & onsite), we provide following training:

 

  • ISO 13485 Overview Training
  • ISO 13485 for the Small Laboratory
  • Developing Medical Devices Quality System Documentation
  • Internal Auditor training
  • ISO 13485 implementation training

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